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NCT01698320 · ClinicalTrials.gov registry record · Phase 3
Safety Study of Albuterol Spiromax® in Subjects With Asthma
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 364
- Enrollment target
NCT01698320: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01698320 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 364 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01698320, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 364 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance through the life of the device during the study.
Primary Outcome
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activitie
Interventions
- DRUG Placebo MDPI
- DRUG Albuterol MDPI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01698320 record still lists
NCT01698320 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo MDPI is the first listed.
NCT01698320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01698320 about?
NCT01698320 is a clinical study titled "Safety Study of Albuterol Spiromax® in Subjects With Asthma". The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance throug...
What is the current status of trial NCT01698320?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 364 participants. The study started on 2012-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01698320?
The interventions under investigation include: Placebo MDPI (DRUG), Albuterol MDPI (DRUG).
Who is sponsoring clinical trial NCT01698320?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01698320's enrollment target sits among peer trials
364 1003rd of 2000 higher than 996 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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